Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT01575808
Description: Adverse events were systematically reported on Case Report Forms
Frequency Threshold: 5.0
Time Frame: None
Study: NCT01575808
Study Brief: Multi-center Study for Stent Graft System for Peripheral Artery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GP1101 Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft None None 47 103 41 103 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation paroxysmal SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Non-sustained ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Bilateral cataracts SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.1 View
Cataract aggravated SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.1 View
Left cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.1 View
Right cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.1 View
Acute gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Diverticulum intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Haemorrhage of digestive tract SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Right inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Small intestinal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Arterial stent occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Hepatic function disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 15.1 View
Allergic reaction to antibiotics SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 15.1 View
Acute pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Influenza A virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Pulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Cataract operation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Chronic subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
In-stent coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
In-stent peripheral artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Malleolar fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Peripheral artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Poisoning by hypnotic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
CRP increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.1 View
Potassium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.1 View
Sugar blood level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.1 View
Insulin hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.1 View
Loss of control of blood sugar SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.1 View
Large intestine carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.1 View
Lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.1 View
Malignant neoplasm of lateral wall of oropharynx SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 15.1 View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Renal failure chronic aggravated SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 15.1 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.1 View
Interstitial pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.1 View
Femoral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View
Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View
Vascular occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 15.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Angina pectoris aggravated SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Anginal attack SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Common cold SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Hypertension aggravated SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.1 View